NEW YORK – Care Access on Tuesday said it will help Eli Lilly enroll a more diverse patient cohort within its Phase III eMonarcHER trial.
The Phase III trial is comparing the activity of Eli Lilly's CDK4/6 inhibitor abemaciclib (Verzenio) plus standard adjuvant endocrine therapy against standard endocrine therapy alone in roughly 2,450 patients with high-risk, early-stage, hormone receptor-positive, HER2-positive breast cancer.
The Boston-based decentralized research organization Care Access will reach out to patients from communities traditionally underrepresented in drug trials, including Black, Hispanic, and LatinX patients, and identify individuals who are eligible and willing to partake in Lilly's study. Care Access will focus particularly on enrolling more Black women with early-stage breast cancer, since they have about a 40 percent higher mortality rate compared to white patients.
Care Access' program, called Sites on Demand, identifies and opens trial sites in underrepresented communities. The organization establishes partnerships with surgical and medical oncologists who treat minority communities and engages them as principal investigators on these decentralized trials. Care Access also employs patient access teams that reach patients in their own communities by partnering with healthcare systems, community centers, physician groups, diversity-focused organizations, and advocacy groups. Finally, Care Access will help to educate patients about clinical trial opportunities.
"[Expanding trial representation] is critical for an illness like breast cancer in which women of color have been historically underrepresented in clinical trials," Amy Davis, Eli Lilly's senior director of oncology clinical development, said in a statement. "Our work with Care Access — an organization equally committed to increasing representation of minority group members in clinical trials — brings us one step closer to achieving these diversity goals."